Penciclovir

There is unlikely to be any cause for concern regarding adverse effects when penciclovir is used in pregnant women as systemic absorption of penciclovir following topical administration has been shown to be minimal.

Since the safety in human pregnancy has not been established, penciclovir should only be used during pregnancy or in nursing mothers on the advice of a doctor, if the potential benefits are considered to outweigh the potential risks associated with treatment.

There is unlikely to be any cause for concern regarding adverse effects when the cream is used in lactating women as systemic absorption of penciclovir following topical administration has been shown to be minimal.

There is no information on excretion of penciclovir in human milk.

Penciclovir has no influence on the ability to drive and use machines.

Summary of the safety profile

Penciclovir cream has been well-tolerated in human studies. Clinical trial experience has shown that there was no difference between penciclovir cream and placebo in the rate or type of adverse reactions reported.

The most common events are application site adverse events.

List of adverse reactions

Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); unknown (cannot be estimated from available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

General disorders and administration site condition

Common: Application site reactions (including skin burning sensation, pain of skin, hypoaesthesia)

Post-marketing surveillance has revealed the following adverse events (all reactions were either localised or generalised). Adverse events from post- marketing experience are difficult to calculate a frequency and therefore the events are listed as unknown frequency.

Immune System disorders

Not known: hypersensitivity, urticarial

Skin and subcutaneous disorders

Not known: dermatitis allergic (including rash, pruritus, blisters and oedema)